Brain injuries are complex and can have multiple severe clinical outcomes. Perinatal (fetal and neonatal) brain injury consists of a large group of conditions that produce mild to severe impairments in motor, visual, auditory and cognitive functions. Hearing loss affects 1 to 3 per 1000 normal newborns and 2 to 4 per 100 of infants who require neonatal intensive care. In the U.S., approximately 500,000 are born preterm each year. Children born preterm are at increased risk for adverse neurological outcomes, ranging from mild learning disabilities to cerebral palsy. Up to 23% of children born prior to 28 weeks of gestation develop cerebral palsy. Beyond perinatal brain injury, it is estimated by the Centers for Disease Control that 1.7 million people sustain traumatic brain injuries annually. With the current clinical tools, prognosis and therapies are limited.
Detection of brain injury is difficult, especially in fetuses and neonates with birth-related injury. Unfortunately, clinical tools such as physical exam, and imaging (CT Scan or MRI) are subjective, not widely available, not sensitive or specific enough and or too costly to identify the fetus or neonate with brain injury. Especially, it represents a challenge in premature infants where the developmental immaturity may mask the injury. There is a great clinical need to identify patients with brain injury because these fetuses and infants are at significant risk of progressing to neurological damage, learning problems and memory loss.